There are numerous instances where persons desire enlargement of the soft tissue in their bodies. The inventor herein has worked extensively in this area by inventing and patenting various devices and methods for growing and enlarging soft tissue through different means. Generally, these devices have been focused on enlarging a woman""s breasts, although other various applications have also been disclosed and described in the inventor""s prior patent filings. Also, generally, these inventions operate under a principal of applying a controlled tension to a patient""s soft tissue such as by applying a vacuum, or through a mechanical structure which induces a tension. Various problems have been solved by the inventor in inventing these devices, many of which have contributed to the efficacy and suitability of these devices for application to a human patient. Various embodiments of these devices have been demonstrated through various trials to be effective when used in a prescribed manner.
A problem which exists universally, and which the inventor herein has encountered with his various inventions, is that of patient compliance. Even the best of medical devices can be rendered ineffective or produce less than desirable results should the patient fail to use the device in the manner in which it is prescribed. In particular, it is anticipated that the inventor""s devices will be prescribed by a medical practitioner for a patient""s wear using a protocol relating to wear times and pressures induced or tensions exerted in the soft tissue. It is expected that a medical practitioner will be able to judge these after a careful examination of the patient and through selection of a prescribed treatment regimen. Although this information will be reliably communicated to a patient, at present there is little guarantee that a patient will indeed follow that prescribed regimen to thus achieve desirable results.
In order to solve these and other problems in the prior art, the inventor herein has succeeded in designing and developing a patient monitoring device which may be readily integrated into a control for any of the inventor""s prior embodiments of a soft tissue enlargement device. This patient monitoring device can include a microprocessor controller having a memory and being linked to one or more sensors. These sensors may sense for example a temperature reading such that when the device is placed adjacent the patient""s soft tissue, the patient""s natural body heat is sensed by the temperature sensor to thereby indicate that the device is being properly worn. Still another possibility for a sensor includes a pressure sensor which can be placed in any of the vacuum lines or under the vacuum domes provided as part of the soft tissue enlargement device to sense when the pump which draws the negative pressure or vacuum has indeed created such a negative pressure or vacuum. This indicates that the patient is indeed wearing the device as the vacuum or negative pressure is created between the device and the patient""s soft tissue. Still another sensor, a third sensor, could also be coupled to the microprocessor controller and provide an additional input of a differential nature, e.g., pressure taken at a different part of the device, or another temperature sensor, or any other convenient parameter which may be monitored and which will provide an indication that the patient is indeed wearing the device as prescribed. For example, a mechanical push button or snap switch having a relatively light pressure actuator may be conveniently placed in a strap or other part of the device which would be actuated as the device would be fastened or secured properly to the patient""s body. Other types of sensors could be thought of by those of skill in the art as would be appropriate to the particular device and application.
By using a microprocessor controller, a clock and memory may be provided as part of the controller or in separate microchips so that the length of time that the sensor is above a preselected threshold can be determined and indicate the amount of time that the patient has been wearing the soft tissue enlargement device. Thus, the amount of time that the soft tissue enlargement device remains unworn may be readily determined as well as the amount of time that the device is being worn, and these times may also be indexed to a time of day to provide an additional degree of reliability for the data being collected. As with any typical microprocessor controller, an output port of the controller may be used to communicate the data to another computer, a display such as a computer monitor, a printer, or other recorder as might be desired to collect the data. In still other applications, it might be desired to telecommunicate the data collected by the patient monitor through a communication link such as through a LAN, WAN, or even the Internet.
While the principal advantages and features of the invention have been described above, a fuller understanding of the invention may be attained by referring to the drawings and detailed description of the preferred embodiment which follows.